Penehyclidine impurity 31 CAS CATO-C4X-130431

Description

Under current pharmacopoeial and regulatory frameworks, quality-control requirements for this class of reference material explicitly involve the control of targets including Penehyclidine impurity 31.

Penehyclidine impurity 31 (CAS CATO-C4X-130431) is a certified pharmaceutical impurity reference standard with the molecular formula C12H15ClO and a molecular weight of 210.70 g/mol.

Owing to a hydroxyl group, an ether linkage, chlorine substitution, an aromatic ring system, Penehyclidine impurity 31 is typically off-white to pale yellow low-melting solid. Its solid-state physicochemical attributes — including a molecular weight of 210.70 g/mol — guide the selection of appropriate sample preparation and analytical techniques. The aromatic system may exhibit native fluorescence, enabling detection with a fluorescence detector (FLD).

This reference standard supports related-substances testing and method development in line with ICH Q3A/Q3B guidance on impurity control, and is suitable for system suitability testing and forced-degradation studies.

The assigned purity is verified by mass-balance and quantitative NMR (qNMR) approaches, with the expanded uncertainty reported at a 95% confidence level (k=2). Batch homogeneity and stability are independently assessed for every lot.

Physical & Chemical Properties

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